Breast cancer Cancer Malignant neoplasm of the breast
Conditions
Interventions
Group 1: immediate autologous extended tissue based LDBR (immediate autologous extended lattissimus dorsi [ALD])
Group 2: staged-delayed autologous extended tissue based LDBR (delayed
Sponsors
University Hospitals of Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women requiring a mastectomy and electing to undergo latissimus dorsi breast reconstruction (LDBR) following a diagnosis of invasive primary breast cancer or ductal carcinoma in situ (DCIS) 2. Technically suitable for a stage delayed autologous extended tissue-based latissimus dorsi (LD) procedure (this includes patients agreeable to a Wise or central reduction pattern reconstruction and a planned contralateral symmetrisation procedure if there is not sufficient volume to reconstruct the breast to its native size) 3. Pre-operative evaluation of the breast and axilla suggest that post-operative radiotherapy (RT) is anticipated according to local RT policy 4. Patient does not express a preference regarding procedure type 5. The capacity to understand the patient information sheet and ability to provide written informed consent 6. The capacity to understand and complete the self report HRQL and General Nordic Questionnaire for Psychological and Social Factors at Work (QPS) questionnaires 7. Physical fitness as per the pre-operative evaluations (electrocardiogram [ECG], chest X-ray [CXR], blood biochemistry) 8. Aged between 25 and 75 years
Exclusion criteria
Exclusion criteria: 1. Prophylactic or risk-reducing surgery (i.e. no malignant or pre-malignant pathology such as lobular carcinoma in situ [LCIS]) 2. Previous radiotherapy to the breast 3. Bilateral synchronous pathology 4. Loco-regional recurrence 5. Previous wide local excision requiring completion mastectomy 6. Pregnancy as confirmed on blood tests or ultrasound examination 7. Evidence of distant metastases as diagnosed by chest X-ray, bone scan, liver ultrasound scan (USS) or computed tomography (CT) chest/abdomen and magnetic resonance imaging (MRI) 8. Previous malignancy except basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin 9. Significant other clinical risk factors and co-morbidities e.g. body mass index (BMI), diabetes, smoker according to local policy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of eligible women who accept randomisation and their subsequent treatment allocation 2. The rationale for women declining randomisation as assessed through the Patient Views on QUEST questionnaire (PVQ) 3. The perceptions of surgeons and breast care nurses regarding equipoise evidence relating to cosmetic appearance, complications and quality of life outcomes through Perceptions of Equipoise Evidence and Randomisation Survey (PEERS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life outcomes, measured at change from baselines to each of the follow-up assessments at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months between allocated treatment groups | — |
Countries
England, United Kingdom
Outcome results
None listed